Frequently asked questions (FAQs)
about vaccinology and the South African 足球竞彩app排名 vaccine trials at Wits University
about vaccinology and the South African 足球竞彩app排名 vaccine trials at Wits University
As at 25 August 2020, Wits University leads two 足球竞彩app排名 vaccine trials, which at this time are the only 足球竞彩app排名 vaccine trials in South Africa and on the continent:
The South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (VIDA).
Professor Shabir Madhi, Executive Director of VIDA, leads both trials.
A vaccine is a biological product that elicits an immune response against a specific bacteria or virus.
The immune response stimulates lymphocytes [white blood cells] in the body to produce antibodies and other inflammatory responses to kill off, inactivate or neutralise the germ when a person is exposed or infected.
The antibody response is generally specific to individual germs, hence the need for different types of vaccines.
Vaccines have been shown to be the most cost-effective health prevention strategy, second only to potable water, in preventing death.
Each year, it is estimated that immunization of children prevents at least 2.5 million deaths.
Immunization is the process whereby a person is made immune or resistant to an infectious disease, typically by the administration of a vaccine.
However, there still remain approximately 1.5 million deaths that could be prevented each year if vaccines were more accessible and widely used.
Vaccines are ideally given to people before they are exposed to a specific virus or bacteria so that their immune system is able to mount an immediate defence against the targeted germ if they are inadvertently exposed or infected.
There are different approaches to developing vaccines, the ultimate aim of which is usually to elicit a functional immune response in order to prevent infection and disease:
Vaccine development usually takes between 10-15 years from time of discovery to licensure. Vaccine development involves multiple experiments [phases] in animals before studies are start in humans, to mitigate safety issues, ensure the vaccine induces appropriate immune responses, and to evaluate whether the vaccine protects against infection or disease in animals before they advance to studies in humans.
In humans, the studies go through various stages of clinical development to ensure that vaccines are immunogenic [able to provoke an immune response in the body], safe, and are able to protect against infection or disease.
These initial studies start with investigations for safety, optimal dosage, and immune responses in a few hundred people (phase 1), before proceeding to larger phase 2 studies, which provide greater insight into safety, immune response, and whether the vaccine protects against disease. This often involves enrolling a few thousand volunteers. These are followed by phase 3 studies, which are much larger and involve ten-thousands participants to test how safe and effective these vaccines are in protecting against disease, and particularly severe diseases.
The clinical development of new vaccines can range between US$5-million to US$1-billion (± R85 million to R170 billion). The cost of manufacturing vaccine varies from less than a dollar to more than US$100 (±R1700) per dose.
Some of these costs include efforts to recoup the cost of investing in the development of the vaccine rather than the actual cost-of-goods.
The cost also varies depending on the complexity of the manufacturing process involved, which differs for the various designs of vaccines.
Reasons put forward by people that are opposed to vaccines (sometimes known as ‘anti-vaxxers’) differ, but are often based on unsubstantiated concerns and rumour-mongering over the safety of vaccines, or that vaccines are a ploy by Big Industry to maximise profits.
Furthermore, the success of vaccines in improving health and reducing the burden of previous major causes of death (e.g., measles and whooping cough), often leads to unfounded complacency on the need for continual immunisation against these life-threatening germs.
Vaccines are among the most powerful tools to mitigate the consequences of life- threatening germs. This applies even more so to germs that infect the respiratory system, which are more efficiently spread between people.
In the absence of a vaccine against 足球竞彩app排名, there is likely to be ongoing spread of the virus that will continue to cause severe illness and death, especially in those older than 65 years and adults with co-morbidities such as obesity, hypertension, and diabetes.
It is possible that, over time, when approximately two-thirds of the population have been infected by SARS-CoV-2, that 足球竞彩app排名 will cause fewer deaths. However, this will depend on whether natural infection with the virus is able to induce a long-lasting and effective immune response.
An effective vaccine against 足球竞彩app排名 can short-circuit the period over which at least two-thirds of the population become immune, which could assist in containing the risk of infection by the virus, even among those not vaccinated.
Furthermore, a 足球竞彩app排名 vaccine will provide direct protection to vaccinated individuals against severe illness caused by SARS-CoV-2, including those individuals at high risk for severe disease.
In the absence of a 足球竞彩app排名 vaccine, we will likely need to continue living the guarded lifestyle we are currently practising for at least two to three years, during which time we can anticipate multiple waves of 足球竞彩app排名 outbreaks.
As with most human vaccines, there were several animal species used in vaccine safety and efficacy trials, including ferrets, mice and Rhesus macaques.
Although the development of this vaccine is on accelerated timeline to address an unprecedented pandemic, the clinical development of the vaccine has built-in reviews processed by an independent international Data and Safety Monitoring Committee, as well regulatory oversight in South Africa by the South African Health Products Regulatory Authority (SAPHRA) and the University of the Witwatersrand Human Research Ethics Committee.
The vaccine will only be licensed for use after adequate studies have been undertaken to confirm its safety and effectiveness.
To assess whether the vaccine works to protect from 足球竞彩app排名, South African and other scientists will compare the number of infections in the control group with the number of infections in the group who received the coronavirus vaccine. If transmission remains high, we may get enough data in a couple of months to see if the vaccine works, but if transmission levels drop, this could take longer.